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  • 1.  Guidelines on Post Approval Changes in India

    Posted 05-Oct-2023 02:17

    Hi 

    Can someone guide me on how to handle Post approval changes (Variation) in India. 
    I retrieved many relevant documents from DCSCO site. But maximum guidelines are applicable for biologics division. I could not find any common guideline applicable to all types of molecule, describing types of variation followed in India.  

    Variation categories described for Bio -as Level I, II, II  & for medical devices - its major, Minor, Moderate.

    It would be great if someone provide me the general Variation filling guidelines (HA link) for country India. It is bit difficult to understand what procedure country follow in general which will be applicable for small molecule  too.

    Thanks in advance.

    Best Regards,

    Pradnya.



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    PRADNYA MHADESHWAR
    Managing Editor - RA
    Hyderabad
    India
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  • 2.  RE: Guidelines on Post Approval Changes in India

    Posted 05-Oct-2023 03:10
    Please refer the Industry guidence document available on CDSCO website...there you will find the relevant details.

    Thanks 



    Original Message


  • 3.  RE: Guidelines on Post Approval Changes in India

    Posted 09-Oct-2023 06:36
    Actually there is no guideline for conventional products or drugs in CDSCO



    Original Message


  • 4.  RE: Guidelines on Post Approval Changes in India

    Posted 09-Oct-2023 05:52

    In India variations are dealt different pathways.

    1. Biologicals and vaccines:  Always considered as new drug. There are well defined guidelines for PACs. All PACs should be submitted to DCGI office. Level 3 (only notification), Level 1 &2 CDL Kasuali and DCGI office approval required. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=Njc2MQ==
    2. Small molecules - New drugs. Locally manufactured. Regulations are silent. Any critical changes should be approved with DCGI office.
    3. Small molecules - Old drugs. Local manufactured.  All changes are manufactured through QMS except shelf life, container closure systems, compendia related changes and any legal changes like change in the name of firm.
    4. Small molecules - New/Old drugs (imported). Following types of change you can find in the SUGAM
      • Addition of site involved in manufacturing of drug
      • Change in address of registered manufacturer in RC (No location change) 
      • Change in foreign manufacturer address in RC (No location change)
      • Change In manufacturing process, or in pkg or labelling or testing or docs
      • Change in Shelf life (Extension)
      • Change of Name of Manufacturer in RC without constitution change
      • Change of pharmacopoeial specification in RC
      • Change of pharmacopoeial specification of Drug ingredients in FF in RC
      • Change of shelf life (Reduction)
      • Deletion of Site involved in manufacturing of drug product



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    AHMED MEERAN DAWOOD ALI
    Gurgaon
    India
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    Original Message


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